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(1)(a) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or

(2)(b) to affect the structure or any function of the body of man or other animals.

(d)(4) The term `Official compendium' means the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any a supplement to any of them.

(e)(5) The term `Label' means a display of written, printed, or graphic matter upon the immediate container of any an article; and. A requirement made by or under authority of this chapter that any a word, a statement, or other information appear on the label shall is not be considered to be complied with unless such the word, statement, or other information also appears on the outside container or wrapper, if any there be one, of the retail package of such the article, or is easily legible through the outside container or wrapper.

(f)(6) The term `Labeling' means all labels and other written, printed, or graphic matter (1) upon any an article or any of its containers or wrappers, or (2) accompanying such the article. If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then in determining whether the labeling or advertisement is misleading, there shall must be taken into account, (among other things), not only representations made or suggested by statement, word, design, device, sound, or in any a combination thereof of them, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of such these representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof of them or under such customary or usual conditions of use as are customary or usual.

(g)(7) The term `New drug' means:

(1)(a) Any a drug, (except a new animal drug or an animal feed bearing or containing a new animal drug), the composition of which is such that such the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that

(2)(b) Any a drug, except a new animal drug or an animal feed bearing or containing a new animal drug, the composition of which is such that such the drug, as a result of investigations to determine its safety and effectiveness for use under such the conditions, has become so recognized, but which has not, otherwise than in such these investigations, been used to a material extent or for a material time under such the conditions.

(h)(8) The term `Color' includes black, white, and intermediate grays.

Section 39-23-30. A drug or device shall be is deemed to be adulterated if it:

(a)(1)(a) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or

(2)(A)(b)(i) if it has been prepared, packed, or held under insanitary conditions whereby where it may have been contaminated with filth, or whereby where it may have been rendered injurious to health; or

(B)(ii) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such the drug meets the requirements of the Federal Food, Drug, and Cosmetic Act, as amended, as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or

(3)(c) if it is a drug and its container is composed, in whole or in part, of any a poisonous or deleterious substance which may render the contents injurious to health; or

(4) if

(A)(d)(i) it is a drug which bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of Section 706(a) of the Federal Food, Drug, and Cosmetic Act, as amended,;

(B) (ii) it is a color additive the intended use of which in or on drugs is for purposes of coloring only and is unsafe within the meaning of Section 706(a) of the Federal Food, Drug, and Cosmetic Act, as amended; or

(5)(e) if it is a new animal drug which is unsafe within the meaning of Section 512 of the Federal Food, Drug, and Cosmetic Act, as amended; or

(b)(2) If it purports or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from or its quality or purity falls below the standard set forth in such the compendium. Such The determination as to strength, quality, or purity shall must be made in accordance with the tests or methods of assay set forth in such the compendium, except that whenever. However, when tests or methods of assay have not been prescribed in such the compendium, or those prescribed under authority of the federal act, or such the tests or methods of assay as are prescribed are, in the judgment of the Commissioner of the Department of Health and Environmental Control, insufficient for the making of such the determination, the Commissioner commissioner shall bring such that fact to the attention of the appropriate body charged with the revision of such the compendium, and. If such the body fails within a reasonable time to prescribe tests or methods of assay, which, in the judgment of the Commissioner commissioner, are sufficient for purposes of this paragraph, then the Commissioner Department of Health and Environmental Control shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such the determination as to strength, quality, or purity shall must be made. No drug defined in an official compendium shall may be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such the compendium, if its difference in strength, quality, or purity from such the standards is plainly stated plainly on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be is subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug in which case. If it is labeled and offered for sale as a homeopathic drug, it shall be is subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.

(c)(3) If it is not subject to the provisions of paragraph (b) of this section, item (2) and its strength differs from, or its purity or quality falls below that which it purports or is represented to possess.;

(d)(4) If it is a drug and any a substance has been (1) mixed or packed therewith with the drug so as to reduce its quality of strength or (2) substituted wholly or in part therefor.

(a)(1) if its label is false or misleading in any particular.;

(b)(2) if in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided. However, that reasonable variations shall be are permitted under regulations issued promulgated by the Commissioner Department of Health and Environmental Control or issued under the federal act. Provided, further, that in the case of any For a drug subject to Section 39-23-50(B)(1), the label shall must contain the name and place of business of the manufacturer of the finished dosage form and, if different, the name and place of business of the packer or distributor. For the purpose of this paragraph item, the finished dosage form of a drug is that form of the drug which is, or is intended to be, dispensed or administered to the ultimate user upon prescription or as otherwise dispensed by the pharmacist.;

(c)(3) if any a word, a statement, or other information required by or under the authority of this chapter or the Federal Food, Drug, and Cosmetic Act to appear on the label or labeling is not prominently placed thereon prominently on the label or labeling with such conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.;

(d)(4) if it is for use by man and contains any a quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane, or any a chemical derivative of such the substance, which derivative, after investigation, has been found to be, and designated as, habit forming, by regulations issued promulgated by the Commissioner Department of Health and Environmental Control under this chapter, or by regulations issued pursuant to Section 502(d) of the federal act, unless its label bears the name and quantity or proportion of such the substance or derivative and in juxtaposition therewith the statement `Warning--May be habit forming.';

(e)(1)(5)(a) if it is a drug, unless:

(A) (i) its label bears, to the exclusion of any other another nonproprietary name, (except the applicable systematic chemical name or the chemical formula), (i)(A) the established name, (as defined in subparagraph (2)) subitem (b), of the drug, if such there be is, and, (ii) in

(B) (ii) for any a prescription drug, the established name of such the drug or ingredient, as the case may be, on such the label, (and on any the labeling on which a name for such the drug or ingredient is used), is printed prominently and in type at least half as large as that used thereon on the label or labeling for any a proprietary name or designation for such the drug or ingredient; and provided, that. However, to the extent that compliance with the requirements of clause (A)(ii) sub-subitem (i)(B) or clause (B) of this subparagraph sub-subitem is impracticable, exemptions shall must be established by regulations promulgated by the Commissioner Department of Health and Environmental Control or under the federal act.

(2)(b) As used in this paragraph (e) item, the term `established name', with respect to a drug or ingredient thereof of the drug, means:

(A) (i) the applicable official name designated pursuant to Section 508 of the Federal Food, Drug, and Cosmetic Act as amended, or;

(B) (ii) if there is no such official name and such the drug, or such the ingredient, is an article recognized in an official compendium, then the official title thereof in such the compendium,; or

(C) (iii) if neither clause (A) sub-subitem (i) nor clause (B) of this subparagraph sub-subitem (ii) applies, then the common or usual name, if any, of such the drug or of such the ingredient; provided, further, that. Where clause (B) of this paragraph sub-subitem (ii) applies to an article recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia shall apply applies unless it is labeled and offered for sale as a homeopathic drug, in which case. If it is labeled and offered for sale as a homeopathic drug, the official title used in the Homeopathic Pharmacopoeia shall apply. applies;

(f)(6)(a) unless its labeling bears adequate:

(1) (i) adequate directions for use; and

(b) provided, that where any a requirement of clause (1) of this paragraph sub-subitem (i), as applied to any a drug or device, is not necessary for the protection of the public health, the Commissioner Department of Health and Environmental Control shall promulgate regulations exempting such the drug or device from such the requirement; provided, further, that. Articles exempted under regulations issued under Section 502(f) of the federal act shall also be are exempt.;

(g)(7) if it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein; provided, that. However, the method of packing may be modified with the consent of the Commissioner of the Department of Health and Environmental Control or if consent is obtained under the federal act. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be is subject to the requirements of the United States Pharmacopoeia with respect to packaging, and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case. If it is labeled and offered for sale as a homeopathic drug, it shall be is subject to the provisions of the Homeopathic Pharmacopoeia of the United States, and not to those of the United States Pharmacopoeia; provided, further, that, in the event of. If there is inconsistency between the requirements of this paragraph item and those of paragraph (e) item (5) as to the name by which the drug or its ingredients shall be are designated, the requirements of paragraph (e) shall item (5) prevail.;

(h)(8) if it has been found by the Commissioner of the Department of Health and Environmental Control or under the federal act to be a drug liable to deterioration, unless it is packaged in such a form and manner, and its label bears a statement of such the precautions, as the Commissioner Department of Health and Environmental Control or under the federal act shall by regulations require requires as necessary for the protection of the public health. No such regulation shall may be established for any a drug recognized in an official compendium until the Commissioner of the Department of Health and Environmental Control shall have informed informs the appropriate body charged with the revision of such the compendium of the need for such the packaging or

(i)(1)(9)(a) if it is a drug and its container is so made, formed, or filled as to be misleading; or

(2)(b) if it is an imitation of another drug; or

(3)(c) if it is offered for sale under the name of another drug.;

(j)(10) if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.;

(k)(11) In the case of any for a prescription drug distributed or offered for sale in any state, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of:

(1)(a) the established name as defined in Section 39-23-40(e) item (5), printed prominently and in type at least half as large as that used for any a trade or brand name thereof,;

(2)(b) the formula showing quantitatively each ingredient of such the drug to the extent required for labels under Section 39-23-40(e), and (3) such item (e);
(c) other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations which shall be issued under the federal act.

Section 39-23-50. (a)(A) The Commissioner Department of Health and Environmental Control is hereby directed to shall promulgate regulations exempting from any a labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, are to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such the drugs and devices are not adulterated or misbranded, under the provisions of this chapter upon removal from such the processing, labeling, or repacking establishment.

(b)(B)(1) A drug intended for use by man which (A) is a habit-forming drug to which Section 39-23-40(d)(4) applies; or (B) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such the drug; or (C) is limited by an effective application under Section 39-23-70 to use under the professional supervision of a practitioner licensed by law to administer such the drug, shall may be dispensed only:

(ii)(b) upon an oral prescription of such the practitioner which is reduced promptly to writing and filed by the pharmacist,; or

(iii)(c) by refilling any such a written or oral prescription if such the refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

(2) The act of dispensing a drug contrary to the provisions of this paragraph shall be item (1) is deemed to be an act which results in the drug being misbranded while held for sale.

(2)(3) Any A drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such the drug shall be is exempt from the requirements of Section 39-23-40, except paragraphs (a) items (1), (i)(2) (9)(b) and (3)(c), (k)(11), and the packaging requirements of paragraphs (g) (7) and (h) (8), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and if stated in the prescription the name of the patient, and the directions for use and cautionary statements, if any, contained in such the prescription. This exemption shall does not apply to any a drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection item (1).

(3)(4) The Commissioner Department of Health and Environmental Control may by regulation may remove drugs subject to Section 39-23-40(d)(4) and Section 39-23-70 from the requirements of paragraph item (1) of this subsection when such the requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the federal act by regulations issued thereunder may under it also by regulations issued promulgated by the Commissioner Department of Health and Environmental Control, may be removed from the requirements of paragraph item (1) of this subsection.

(4)(5) A drug which is subject to paragraph item (1) of this subsection shall be is misbranded if at any time prior to before dispensing its label fails to bear the statement `Caution: Federal law prohibits dispensing without prescription.' A drug to which paragraph item (1) of this subsection does not apply shall be is deemed to be misbranded if at any time prior to before dispensing its label bears the caution statement quoted in the preceding sentence.

Section 39-23-55. (A) For purposes of this section, `sample' means a unit of a drug which is not intended by the manufacturer to be sold and which is intended to promote the sale of the drug.

(B) The department may not require the labeling of a prescription or nonprescription drug sample for which a physician does not require a federal or state controlled substance license to dispense, when the physician dispenses it to a patient for no charge. If the sample is not in the manufacturer's original package, the physician shall label it meeting all requirements of nonsample prescription medication. If adequate directions for usage are not provided on the manufacturer's package, the physician shall give adequate written directions.

(C) The labeling exemption established in this section does not apply when more than one hundred twenty dosage units or a thirty-day supply of a drug in solid form or eight ounces of a drug in liquid form is dispensed.

Section 39-23-60. In accordance with federal standards, the Commissioner Department of Health and Environmental Control shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in drugs for purposes of coloring only and for the certification of batches of such the colors, with or without harmless diluents.

Section 39-23-70. (A) No person shall may introduce or deliver for introduction into intrastate commerce any a new drug unless an application filed pursuant to subsection (B) is effective with respect to such the drug, or an application with respect thereto to the drug has been approved and such the approval has not been withdrawn under Section 505 of the federal act.

(B) Any A person may file with the Commissioner of the Department of Health and Environmental Control an application with respect to any a drug subject to the provisions of subsection (A). Such The persons shall submit to the Commissioner of the Department of Health and Environmental Control as a part of the application:

(1) full reports of investigations which have been made to show whether or not such the drug is safe for use;

(2) a full list of the articles used as components of such the drug;

(3) a full statement of the composition of such the drug;

(5) such samples of such the drug and of the articles used as components thereof of the drug as the Commissioner of the Department of Health and Environmental Control may require; and

(6) specimens of the labeling proposed to be used for such the drug.

(C) An application provided for in subsection (B) shall become is effective on the one hundred eightieth day after the its filing thereof, except that if. However, the Commissioner of the Department of Health and Environmental Control, before the effective date of the application, shall issue an order refusing to permit the application to become effective if he finds, after due notice to the applicant and giving him an opportunity for a hearing,:

(1), that the drug is not safe or not effective for use under the conditions prescribed, recommended, or suggested in the its proposed labeling thereof; or

(2) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such the drugs are inadequate to preserve its identity, strength, quality, and purity; or

(3) based on a fair evaluation of all material facts, such the labeling is false or misleading in any particular; he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.

(D) If The Commissioner of the Department of Health and Environmental Control, before the effective date of the application, shall issue an order refusing to permit the application to become effective if he finds, after due notice to the applicant and giving him an opportunity for a hearing, that:

(1) the investigations, reports of which are required to be submitted to the Commissioner commissioner pursuant to subsection (B), do not include adequate tests by all methods reasonably applicable to show whether or not such the drug is safe for use under the conditions prescribed, recommended, or suggested in the its proposed labeling thereof;

(2) the results of such the tests show that such the drug is unsafe for use under such the conditions or do not show that such the drug is safe for use under such the conditions;

(3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such the drug are inadequate to preserve its identity, strength, quality, and purity; or

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